Rotavirus is a leading cause of severe diarrhea in children under 5 years old, with an estimated 25 million outpatient visits and over 2 million hospitalizations attributable to rotavirus infections each year. Despite the availability and use of vaccines, rotavirus remains a significant cause of severe diarrhea. The virus is particularly prevalent in low- and middle-income countries, where it is responsible for 250 million episodes of diarrhea and 128,500 deaths annually.

A study estimated the rotavirus vaccines on the market saved almost 140,000 children from 2006 to 2019. These vaccines are highly effective against diarrhea of any severity in developed-world settings.  However, they are limited in protecting the children most in need due to their substantial decrease in effectiveness in low-income countries. Furthermore, there is a small increased risk of intussusception, a form of bowel obstruction that can cause serious damage to the intestines in vaccinated individuals. Its occurrence rate is between 1 and 7 cases per 100,000 doses in the 7 days following both the first and second doses.

In addition to these concerns, there are also programmatic issues such as a large cold-chain footprint and insufficient global vaccine supply. These factors highlight the inadequacy of the current vaccines and underscore the need for continued research and development in this area.